NON-FINAL REJECTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group III in the reply filed on 04/10/2026 is acknowledged. Thus, claims 12-20 are elected. Claims 1-11 are withdrawn. Considering the applicant’s election, the examiner is now examining the claims 12-20.
Claim Objections
Claims 12-13 are objected to because of the following informalities:
In claim 12, line 5, recitation of “receive prefilled syringe (PFS) break loose and extrusion resistance (BLER) data” is not fully clear. Is “break loose and extrusion resistance (BLER) data” is of “prefilled syringe (PFS)”? If so, Examiner suggest to replace “receive prefilled syringe (PFS) break loose and extrusion resistance (BLER) data” with “receive prefilled syringe’s (PFS) break loose and extrusion resistance (BLER) data” or with “receive break loose and extrusion resistance (BLER) data of prefilled syringe (PFS).”
In Claim 13, a full stop “.” is missing.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
As to Step-1 test: result-YES (a method or an apparatus).
Claims 12-20 are related to a process or method and thus, the claims pass Step-1 test.
As to Step-2A test: result-NO (Abstract idea of itself).
Claims 12-20 are rejected as not being directed to patent eligible subject matter because the claims are directed to a judicial exception, specifically the recitations of “receive prefilled syringe (PFS) break loose and extrusion resistance (BLER) data, wherein the BLER data is representative of an amount of force required to achieve respective extrusion speeds; “receive rear sub-assembly (RSA) output force profile data; and “generate an injection time (IT) model for the autoinjector based on the BLER data and the RSA output force profile data” are directed to a mathematical procedure for converting one form of mathematical representation to another and therefore the claims are directed to an abstract idea.
The claim recites the steps of “receive … (BLER) data”, “receive … force profile data; and “generate an injection time (IT) model … based on the BLER data and the RSA output force profile data,” which is an abstract idea similar to the concepts that have been identified as abstract by the courts, such as – Collecting information, analyzing it, and displaying certain results on the collection and analysis (Electric power Group); Collecting and comparing known information (Classen); Organizing information through mathematical correlations (Digitech); Data recognition and storage (Content Extraction); Comparing new and stored information and using rules to identify options (SmartGene) - that are directed to mathematical concepts such as mathematical algorithms, mathematical relationships, mathematical formulas, and calculations (or Mathematical Relationships/Formulas or Mathematical procedures for converting one form of mathematical representation to another) which the court has found as an abstract idea.
As to Step-2B test: result-NO (Well known in the Art).
The remainder of the claim limitations, e.g. “wherein the BLER data is representative of an amount of force required to achieve respective extrusion speeds”, is not an abstract idea, however, the limitation is not found to be significantly more since the limitation is routine and conventional as the structure is well known in the art, as disclosed in the Kamen art for example, and the functions of the known structures are directed to adding insignificant extra-solution activity (e.g. mere data gathering or data outputting in conjunction with the abstract idea). Therefore, the claims are not directed to additional elements that amount to significantly more than judicial exception.
It is noted that Alice made it clear that different statutory categories should not be treated differently with regard to analysis of eligible subject matter.
Conclusion
The following prior arts made of record and not relied upon, are considered pertinent to applicant's disclosure:
Rini et al. (US 11,744,949 B2) teaches a medical device comprising: an insulin pen with a pen needle attached thereto, a first force sensor arranged on a hub face of the pen needle, a second force sensor arranged on a thumb button of the insulin pen, a microcontroller that receives a first signal from the first force sensor and a second signal from the second force sensor during an injection; wherein the microcontroller is programmed to determine, from the first and second signals received during the injection, a force over time profile, and based on the determined force over time profile, whether or not the injection was properly administered; and at least one of an audible indicator and a visual indicator controlled by the microcontroller (Claim 1).
Dyer et al. (US 12,465,689 B2) teaches an approach to providing predictable and uniform drug delivery across many instances of an automated drug delivery procedure involves measuring features of the drug delivery system prior to delivery. An automated drug delivery procedure is configured to compensate for or otherwise accommodate the impact of these features based on the measured features. In some examples, the measured features are encoded by value or by reference to an external database onto the drug containing component, for example, by affixing a tag (e.g., RFID, barcode, etc.) to the component. At the time of drug delivery, the features are accessed, for example using the affixed tag, and the drug delivery procedure is controlled according to the features [Abstract].
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUMAN NATH whose telephone number is (571)270-1443. The examiner can normally be reached on M to F 9:00 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOHN BREENE can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUMAN K NATH/Primary Examiner, Art Unit 2855
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